scPharmaceuticals downgraded to Market Perform at Leerink. As previously reported, Leerink analyst Ami Fadia downgraded scPharmaceuticals to Market Perform from Outperform and lowered her price target on the shares to $5 from $12. The analyst believes that the new West Pharma device that the company now plans to use for Furoscix will likely have a smoother regulatory path given that this device is already approved by the FDA. However, this also adds additional development work yet to be agreed upon with FDA and pushes out launch timelines potentially by another year, she contends. Fadia adds that these new timelines also put a financing overhang on the stock as scPharmaceuticals will most likely need to explore additional financing before a regulatory submission. Further, the analyst does not see enough positive catalysts between now and an FDA submission to offset the risk of dilution from a potential capital raise.

scPharmaceuticals (SCPH) announced it has signed a development agreement with West Pharmaceutical Services, Inc. (WST) to incorporate West's SmartDose Drug Delivery System with FUROSCIX. FUROSCIX is scPharmaceuticals' lead program for the treatment of edema in patients with heart failure. Based on the Company's interactions with the FDA since June 2018, including the previously disclosed clarifications on additional human factors and validation studies necessary to advance FUROSCIX using the existing delivery technology, scPharmaceuticals elected to expedite the advancement of a next-generation on-body delivery system with a pre-filled cartridge. The development agreement with West represents an important milestone in advancing the FUROSCIX program. scPharmaceuticals sees 2018 year-end cash of $82M-$87M and 2019 expenditures of $8M-$10M per quarter.

scPharmaceuticals announced that it received minutes from the Type A Post-Action Meeting held on September 24 between the company and the FDA to discuss the company's new drug application, or NDA, for Furoscix, scPharmaceuticals' lead program for the treatment of edema in patients with heart failure. The meeting was scheduled to allow scPharmaceuticals to present new information that the company believes important in addressing certain issues raised by the FDA in the complete response letter, or CRL, received on June 13, regarding Furoscix. As an outcome of the meeting, the FDA has asked the company to conduct additional human factors studies and a dose delivery validation study with the recently modified Furoscix Infusor. The company intends to submit requests for Type C meetings with the FDA to determine study protocols. The FDA has not requested any additional clinical trials. The FDA confirmed the appropriate populations for Furoscix are patients with worsening NYHA Class II and III heart failure who display reduced responsiveness to oral diuretics and do not require hospitalization. The FDA has recommended that the label for Furoscix, if approved, should state that the Furoscix Infusor should not be used as a substitute for IV diuretics for patients who require hospitalization or have been recently discharged.

scPharmaceuticals' Furoscix ultimately to reach the market, says BMO Capital. BMO Capital analyst Gary Nachman kept his Outperform rating and $14 price target on scPharmaceuticals after its Q2 results, saying the investors' focus remains on the company working through the FDA complete response letter for its Furoscix drug. The analyst notes that the management intends to address the issues raised by the FDA with its September 24th update, adding that after a 1-2 year delay, he still expects the drug to reach the market.

scPharmaceuticals price target lowered to $12 from $20 at Leerink. Leerink analyst Ami Fadia lowered her price target for scPharmaceuticals to $12 from $20 after the company announced that it received a Complete Response Letter from the FDA on Furoscix. The analyst believes that making changes to the design of the device - should the FDA ultimately require it - is no small task and a resubmission involving this will likely take longer than her previous 6-12 month delay estimate to fully complete. In light of this uncertainty, Fadia pushes out approval of Furoscix by 2 years to mid-2020. The analyst reiterates an Outperform rating on the shares.

scPharmaceuticals price target lowered to $12 from $26 at Jefferies. Jefferies analyst David Steinberg lowered his price target for scPharmaceuticals to $12 after the company received a Complete Response Letter for its heart failure product candidate Furosci. The letter, which indicated the need for additional human factor studies, device modifications, and a possible clinical validation study, is "arguably more onerous than previously expected," Steinberg tells investors in a research note. The analyst, however, continues to view Furoscix as approvable and keeps a Buy rating on scPharmaceuticals.

scPharmaceuticals' Furoscix 'still alive' despite CRL, says BMO Capital. BMO Capital analyst Gary Nachman said scPharmaceuticals' announcement of a Complete Response Letter, or CRL, from the FDA regarding its application for Furoscix was "disappointing but expected." Nachman, who still believes there will be an ultimate path forward for Furoscix, is now assuming a one to two year delay and is lowering his estimates. He maintains an Outperform rating on the stock, but lowered his price target for scPharmaceuticals shares to $14 from $24.